A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Major Science and Technology Special Project of China Eleventh Five-year

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01086085

First received: March 11, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2010

Last Updated Date

May 7, 2013

Start Date ^ICMJE

April 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) [ Time Frame: Weeks 72, 96, 120 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Quantitative HBsAg reduction [ Time Frame: Weeks 72, 96 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01086085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml [ Time Frame: Weeks 24, 48, 72, 96, 120 ] [ Designated as safety issue: No ]
Safety: Adverse Events [ Time Frame: From baseline to Week 120 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: HBeAg loss/seroconversion [ Time Frame: Weeks 48, 72, 96 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

Official Title ^ICMJE

A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.

Brief Summary

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis B, Chronic

Intervention ^ICMJE

Drug: peginterferon alfa-2a [PEGASYS]
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Drug: peginterferon alfa-2a [PEGASYS]
Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Drug: peginterferon alfa-2a [PEGASYS]
Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
Drug: Adefovir
Adefovir 10 mg po once daily for 36 weeks

Study Arm (s)

Experimental: A
Intervention: Drug: peginterferon alfa-2a [PEGASYS]
Experimental: B
Intervention: Drug: peginterferon alfa-2a [PEGASYS]
Experimental: C
Intervention: Drug: peginterferon alfa-2a [PEGASYS]
Experimental: D
Interventions:
- Drug: peginterferon alfa-2a [PEGASYS]
- Drug: Adefovir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

265

Estimated Completion Date

December 2013

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients >/=18 years of age
HBeAg positive chronic hepatitis B
Compensated liver disease

Exclusion Criteria:

Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
Antiviral, anti-neoplastic or immunomodulatory treatment
Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
Evidence of decompensated liver disease
Chronic liver disease other than viral hepatitis

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01086085

Other Study ID Numbers ^ICMJE

ML22266

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Major Science and Technology Special Project of China Eleventh Five-year

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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